Laura Munteanu Email & Phone Number

Bucharest, Romania

Bucharest, Romania

Leading the Medical Department in GSK Romania covering the following functions: Medical Affairs, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Product Quality and Patient Advocacy. Ensuring all activities under medical accountability are implemented at high ethical and compliance standards, in line with GSK operating practices and local legislation. •Owner of the Medical Affairs strategy, ensuring the necessary skills and resources are available;•Leading the Drug Regulatory strategy by supporting licence approvals, business development, market access and effective product launch & supply. Ensure that all legal requirements in regard to the licensing and sale of GSK medicines in Romania are consistently met.•Responsible for meeting the country KPIs in terms of clinical trials, while ensuring the safety and standards adherence; maintaining the local performance of the Clinical Operations in respiratory portfolio as footprint country and develop the oncology and immunology portfolio;•Leading the Medical Governance to ensure legal and regulatory responsibilities of marketing authorizations for GSK products and wholesale/import /controlled drug license are adhered to, and that the highest standards of regulatory compliance and quality are maintained to limit and mitigate regulatory risk to the business. •Direct overseeing the PVfunction; ensure full compliance with adverse event reporting to meet statutory regulations.•Owner of the Patient Advocacy strategy; design and implementation in line with the Global requirements and country specificity;•Ensuring Medical Governance and ethical principles/standards are understood, adhered to and enhanced.Member of the local Risk Management and Compliance Board •Representing GSK in relationship with the local authorities in medical related matters; •Member of the European Leadership team; •Member of the Country Executive Board of Directors;

Bucharest, Romania

•Leading all aspects of local Medical Affairs activities including planning, execution and associated resource allocations in alignment and close collaboration with local organization and in line with corporate codes of practice, company operating practices ,local legislation and global Medical Affairs strategy for all GSK therapeutical areas ( respiratory, oncology,haematology, neurology, psychiatry, urology, HIV, rare diseases,vaccines, cardiology, anti-infectives, anesthesia, thrombosis ,dermatology)•Leading the External Medical partnerships process working to develop and maintain strong relationships with key opinion leaders, investigators, payers, regulators, patient associations and healthcare organisations and ensure that significant developments in the field are identified and monitored: - Coordinating External Experts mapping and development process - Gaining strategic insights from these relationships and input intelligence gained into the medical/marketing plans - Leading the delivery of medical education activities,local advisory boards,scientific communication in medical congresses/scientific partnerships with medical societies/scientific symposia / 1:1 meetings, - Delivery of local scientific publications and communications - Coordinating the delivery of Medical Information activities - Leading the scientific exchange with the Romanian medical community for the products in pre-authorisation phase Medical Affairs being the unique point of contact•Internal partnerships and engagementSupporting effective Medical-Marketing collaborationsActing as final signatory for any external medical communication Coordinating and ensuring product / disease and therapies training to internal customers.•Leading the local Evidence Planning strategyPartnership with Market Access and Corporate Affairs in developing the requirements of the reimbursement filesEnsuring the clinical trials feasibility assessments for all the clinical trials

Bucharest, Romania

Providing expert scientific knowledge on Sandoz key prescription brands, competitors & the healthcare environment - input into brand strategy and development of promotional claims•Review and final approval for any product related materials to ensure information and claims are relevant to the Country environment, in accordance with local medical practice;•Managing issues which potentially threaten Sandoz brands to help maintain the company‘ competitive position in the market•Ensuring ethical and credible promotion for the key brands in accordance with Sandoz Promotional Practices guidelines and local legislation• Coordinating the delivering of the scientific knowledge tailored to the medical representatives’ needs (content, schedule, tests), representatives enquiries, presentations, memos•Managing the post-marketing studies - develop and implement post-marketing trials and support investigator led studies to improve the clinical and commercial impact of Sandoz portfolio(cardiology, neurology, oncology, respiratory, anti-infective, biosimilar products) •Managing the implementation of Risk Management Plans •Local implementation for global medical projects•Medical input for the local pharmacovigilance and medical writting team•Managing the sampling process, as per legal requirements and group standards•Representing the company in relation with responsible stakeholders from Ministry of Health, National Insurance House, National Drug Agency, Generic Producers Association, internal and external (incl. HQ) forums•Analizing the business environment and monitoring the legislation with impact on healthcare and generic business•Developing appropriate pricing policy, getting favorable reimbursment for new products

Bucharest, Romania

Leading the Human Resources function covering the Commercial Operations organization and the Manufacturing Site from Targu Mures.

Bucharest, Romania

•Proactively establishing strong working relationship with client group (250 employees)•Defining the recruitment and selection strategyin line with business strategy, ensuring all positions are filled in time•Ensuring availability of up-dated role profiles, job grading and remuneration levels( salary and sales bonuses) for all position •Preparing the annual compensation budget and negotiating it with Finance; monthly monitoring the actuals and preparing the budget for intermediary estimations;•Driving annual salary review process, approving off- cycle salary changes, in line with company rules and available budget•Providing guidance and counseling to line management on difficult and/or complex employee performance issues•Implementation of the succession planning for key positions in the organization (direct reports to country head and key positions in the sales organization)•Development activities on all levels to enhance current performance and to prepare for future assignment•Designing and implementing new organizational model to address the changes in the business strategy (coordination of the country management team in a project of organizational expansion but also leading the management team operating the organization downsizing)•Designing and updating the company policies and procedures according to regulatory changes and/or group requirements•Minimizing legal risk/exposure by ensuring that disciplinary and exit strategies are handled appropriately•Conducting the annual negotiation of Collective Labor Contract between the Employer and Workers Council

Bucharest, Romania

•Training needs assessment in consultation with departmental heads (Mk & Sales, Finance , Regulatory Affaires, Human Resources, Legal, Supply Chain)•Annual training plan designing, implementation and deviation tracking.•Identifying , selecting and managing the external training agencies; •Delivering the training programs included in the induction kit ( selling skills, professional communication, presentation skills, coaching techniques, performance management)•Training managers how to “coach and develop” their staff; ensuring that the line managers are informed and proficient in applying the best training ideas and methods ;•Coaching & counseling managers as well as medical representatives on developmental issues ( individual development plans)•Planning the departmental budgets & cost tracking;•Medical representatives evaluation in the field; •Coordinating the implementation of the performance appraisal process in the commercial organization according with Novartis guidelines( direct the mid-year and end-year performance process, analyzing activities, incentive program, correction measures for “bad performers”)

• Reporting to the Marketing & Sales Manager with responsibility for 23 counties and Bucharest;• Responsible for maintaining the sales operations within the assigned territory; • Responsible for managing a team of 15-45 medical/sales representatives – antiinfectives cardiology, neurology portfolio

Romania

Timis County, Romania

Romania

Doctor Of Medicine (Md), Medicine

Mba, Business

Doctor Of Philosophy - Phd, Medicine, Phd

MAGNA CUM LAUDE